Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT03818594
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed consent form (ICF),
* Caucasian race
* Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
* Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources
* Willingness to follow all study procedures
Exclusion Criteria:
* Pregnancy or breastfeeding,
* Known or suspected allergy to any ingredient of the tested products in Part 2,
* Pronounced avoidance of sunshine (eg reporting of allergy to the sun)
* Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,
* Special dietary habits used by a small part of the population (veganism, low-carb hihg-fat diet, caloric restriction diet, note: vegetarians are not excluded)
* Diets prescribed by the medical profession
* Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases
* Other diseases and conditions that affect the absorption and synthesis of vitamin D
* Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium),
* The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D,
* Visiting the solarium in the last three months before joining the survey,
* Mental incapacity that precludes adequate understanding or cooperation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03818594
Study Brief:
Protocol Section:
NCT03818594